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Mindfulness Based Stress Reduction for High Blood Pressure

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ClinicalTrials.gov Identifier: NCT00440596
Recruitment Status : Unknown
Verified May 2009 by National Center for Complementary and Integrative Health (NCCIH).
Recruitment status was:  Recruiting
First Posted : February 27, 2007
Last Update Posted : May 19, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
Nearly 60 million adults in the United States have high blood pressure (BP) in the pre-hypertension (SBP 120-139 or DBP 80-89). Hypertension is estimated to account for 1 in 8 deaths in the world, and in the US the direct and indirect costs of high BP are estimated to reach $59.7 billion in 2005. JNC-7 guidelines recommend lifestyle modifications for prehypertension, followed by antihypertensive medication if BP progresses to Stage I hypertension. Mindfulness-based Stress Reduction (MBSR) is an increasingly popular practice that has been purported to alleviate stress and treat certain health conditions. Some stress management therapies and one meditation therapy (e.g., Transcendental Meditation) have shown promise in reducing elevated BP, but MBSR has not been evaluated as a treatment for high BP. When added to lifestyle modification advice, MBSR may be an appropriate complementary treatment for prehypertension. However, prior to a large randomized clinical trial of MBSR for prehypertension and/or hypertension, pilot data is necessary to provide preliminary evidence of a treatment effect and to evaluate feasibility. This feasibility randomized clinical trial of MBSR for unmedicated prehypertension will provide preliminary evidence to support a larger randomized clinical trial by evaluating the feasibility and safety of MBSR as a complementary treatment for high BP and by documenting any treatment effect. Sixty patients with unmedicated BP in the range of SBP 120-139 mm Hg or DBP 80-89 mm Hg will be randomly assigned to MBSR or a progressive muscle relaxation control condition. All patients will receive lifestyle modification advice. Patients will complete 8 weeks of MBSR delivered in a group format by an experienced psychologist trained in MBSR or 8 weeks of progressive muscle relaxation training matched for therapist contact and homework. Patients BP will be assessed prior to randomization and following treatment by researchers blind to treatment assignment. Accrual rates, acceptance of randomization, treatment adherence, treatment fidelity, and patient satisfaction with treatment will be evaluated.

Condition or disease Intervention/treatment
Hypertension Behavioral: Mindfulness based stress reduction Behavioral: Progressive Muscle Relaxation

Detailed Description:
See brief summary

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness Based Stress Reduction for High Blood Pressure
Study Start Date : September 2006
Estimated Primary Completion Date : May 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: MBSR
Mindfulness based stress reduction
Behavioral: Mindfulness based stress reduction
8 weeks group MBSR
Active Comparator: PMR
Progressive Muscle Relaxation
Behavioral: Progressive Muscle Relaxation
8 weeks PMR in group format


Outcome Measures

Primary Outcome Measures :
  1. SBP [ Time Frame: 12 weeks ]
  2. DBP [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • prehypertension
  • 30-60 years of age

Exclusion Criteria:

  • normal BP
  • hypertension
  • pregnancy
  • smoking
  • use of antihypertensive medication
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440596


Contacts
Contact: Joel W Hughes, Ph.D 330-672-7721 jhughes1@kent.edu
Contact: David Fresco, Ph.D. 330-672-4049 dfresco@kent.edu

Locations
United States, Ohio
Summa Health System Recruiting
Akron, Ohio, United States, 44304
Contact: Richard Josephson, MD    330-253-8195    josephsonr@akcardio.com   
Principal Investigator: Josephson Richard, MD         
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Joel W Hughes, Ph.D. Kent State University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joel W. Hughes, PhD, Kent State University
ClinicalTrials.gov Identifier: NCT00440596     History of Changes
Other Study ID Numbers: R21AT002698-01A2 ( U.S. NIH Grant/Contract )
0760
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: May 19, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases